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Associate II, Quality Control Bioassay

Moderna Therapeutics

Associate II, Quality Control Bioassay

Norwood, MA
Full Time
Paid
  • Responsibilities

    Associate II, Quality Control (Bioassay) Associate II, Quality Control (Bioassay) The Role: Reporting to the Senior Manager of Quality Control (Bioassay), the Bioassay Quality Control Associate II will support cGMP Bioassay method transfer, qualification and release testing for QC raw material, drug substance and finished product testing for mRNA products produced at Modernas manufacturing facility and affiliated contract organizations. The individual will have a focus on Molecular Biology analytics, including Sequencing, qPCR and Primer Design. He/she will troubleshoot assay methods and equipment and support investigations for OOS and other non-conforming results. He/she will contribute to the implementation of bioassay testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting. The individual will collaborate with various groups including Manufacturing, Quality Assurance and Development. This position is 4-days per week, 10 hours per day. Schedule will either be Sunday Wednesday or Wednesday Saturday days. Heres What Youll Do: * Qualify and execute GMP QC Molecular Biology methods, focusing on DNA Sanger Sequencing and qPCR * Collaborate with development groups for method transfers and qualifications in support of expanding the cGMP QC Bioassay laboratory capabilities * Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies * Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements * Conduct technical assessments of deviations and investigations * Provide support to QC management, including the coordination and scheduling of routine testing and lab operations * Perform general laboratory support activities including reagent preparation, equipment maintenance, etc. * Write/revise SOPs, protocols and reports * Train other laboratory staff on method execution and troubleshooting * Provide support to audit teams for internal and vendor audits Heres What Youll Bring to the Table: * BS in a relevant scientific discipline with 0-2 years Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing * Knowledge of Sanger Sequencing, preferably with the Applied Biosystems 3500XL Genetic Analyzer * Experience with gel electrophoresis, qPCR, and other molecular biology techniques * Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations * Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way * Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment * Ability to collaborate effectively in a dynamic, cross-functional matrix environment * Excellent communication skills (verbal and written) Heres What Well Bring to the Table: * Daily on-site catered lunches * Company-provided iPhone * Free parking, monthly subway pass or a subsidized commuter rail pass * Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP * Flexible Spending Accounts for medical expenses and dependent care expenses * 16 weeks of 100% paid parental leave for all new parents * 16 weeks 100% paid family caregiver leave * 20 weeks 100% paid medical leave * Adoption assistance and discounts to local childcare centers, as well as access to care.com * 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately * A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability * Voluntary legal assistance plan * 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays Why join Moderna Therapeutics We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured at a breadth, scale and speed not common in the biopharma industry. Since our founding in 2011, we have built the industrys leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage. We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world. Our Mission: Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. #LI-PL1 Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

  • Industry
    Biotechnology